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Cognizant Reports

Pharmaceutical Supply Chains Require


New Operational and Technology Models
to Enable Collaboration and Efficiency
To combat slowed growth and industry pressures, pharmaceuticals
companies must embrace demand-chain thinking and cloud-enabled
solutions to become more agile, flexible and able to share data in
real-time with partners, from contract manufacturers and CMOs,
through 3PLs and retailers.

cognizant reports | October 2013

Executive Summary
The pharmaceuticals industry is facing an era of
transformation, from the supply chain to the distribution channel. Supply chains are stressed by
SKU proliferation, demand variability and lower
margins. Meanwhile, expiring patents and heightened competition from generics have curbed
the top-line potential of branded pharmaceutical
business units. And finally, pharmaceutical distribution channels must address the increased
use of online ordering and direct-to-customer
delivery processes.
All of these factors, coupled with looming
regulatory mandates, are compelling pharma
businesses to rethink their supply chains and IT
strategies and develop more collaborative models
that enable them to be more agile, flexible and
compliant.
In many ways, pharmaceutical operations and IT
have traditionally been self-contained within the
enterprise. When they reached out to external
stakeholders, such as suppliers, customers and
distributors, it was mainly for transactional
purposes. It is only recently that the industry
has begun to build collaborative networks that
connect partners across the value chain, as seen
in other industries. These networks will help the
industry better manage drug supplies in the
face of increasingly unpredictable demand, gain
better visibility into inventory across the value
chain and service diverse markets.
In this paper, we explore the business and IT
imperatives of trying to refocus supply chain
strategies along these lines. We also explain
how communication among stakeholders in the
pharmaceuticals value chain can become more
proactive, and we describe how cloud-enabled
platforms can provide a common platform to
connect and share data. Companies that follow
these guidelines can engender trust and align
incentives through greater transparency and
accountability.

Symptoms of Declining Health


Industry experts acknowledge that the pharmaceuticals industry will continue to experience reduced profit margins as a result of the
dwindling pipeline of branded products and growing competition from generics. In fact, revenue
growth of the top 100 pharma companies has
fallen to 2%-4% during 2011-12, from 11%-14%
during 2003-2007.1

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While growth is slowing, product pricing is


increasingly restrained by payer organizations.
The average operating margin for large pharmaceuticals companies is forecast at around 20%
in 2013 compared with over 24% from 2003 to
2009.2 This is a sharper decline than seen in the
early 2000s, when there were fewer pharmaceutical products, more stable demand and comfortable margins.3
While growth and operating margins are being
squeezed, supply chains are stretched to reduce
costs in the face of increasing regulatory scrutiny,
M&A activity and expansion into emerging markets.
As top-line growth slows and operating margins
narrow, companies must address their operational
inefficiencies. The pharmaceuticals supply chain
lags behind other industries in multiple ways, but
by addressing manufacturing and equipment lead
times, obsolescence and inventories, these firms
could expect to boost profit margins 9% to 11%.4
While pharmaceuticals firms can increase operational efficiencies in multiple ways, such as
implementing more efficient and high-throughput manufacturing and packaging techniques,
there are also some relatively low-hanging fruits.
Enterprises can readily leverage the following
opportunities to boost their operating margins
in the short (one to three years) and medium
terms (four to six years):

Optimizing inventory throughout the supply


chain: Due in part to inadequate incentives in
the supply chain, the pharmaceuticals industry
maintains higher inventory levels than most
other industries. This issue is compounded
by the rapid SKU proliferation generated by
the emergence of generics. The expensive
returns and destruction process of expired
products raise the cost of obsolescence and
overage inventory beyond that of comparable
industries.
Improving inventory visibility across the
supply chain: Serialization and track/trace
initiatives not only facilitate regulatory
compliance, but they can also prevent costly
product recalls and limit the risk of revenue
loss through product diversion and counterfeiting. They also contribute to inventory
reduction by providing data on inventory from
downstream supply chain partners, which can
be leveraged to model demand and regulate
drug supply. This can result in supply chain

efficiencies both within the four walls and


across the extended supply chain.
Customizing supply chains for regional
products and markets: A one-size-fits-all
supply chain can efficiently manage only one
product category. By increasing supply chain
diversity and moving prodBy increasing ucts between supply chains
supply chain according to market conorganizations can
diversity and ditions,
reduce product, overhead
moving products and inventory costs while
between supply providing better service for
customers.

chains according to
market conditions,
organizations can
reduce product,
overhead and
inventory costs
while providing
better service for
customers.

Taking Action

Historically,
comfortable
returns from blockbuster
and branded drugs have
resulted in complacency
among
pharmaceuticals
firms in terms of instituting
supply chain improvement
measures or collaboration
with external stakeholders. Typically, pharmaceuticals enterprises have closely guarded sales
forecasts and manufacturing pipeline information. They have also tended to deploy
largely independent ERP systems that serve

their core operations very well but do little to


help them interact with stakeholders beyond
purchases and sales orders. However, there is
much to be gained from gathering and making
use of data from supply chain partners.
We perceive the need for shifting the conventional
mindset from a traditional, compartmentalized
enterprise to an extended virtual enterprise
that entails a more collaborative model. The
result: Proactive sharing of demand and inventory
data across the value chain. In practice, this cannot be achieved without two key prerequisites:

Business trust among value chain stakeholders. This includes suppliers (especially
those deemed strategic and part of the
virtual supply chain), manufacturers, 3PLs,
retailers, etc. Trust is built over time by
aligning the incentives of each stakeholder,
leveraging risk-sharing approaches.
Scalable and secure IT platforms that
facilitate real-time or near real-time visibility
of data across the extended supply chain.
Most ERP systems in use today were designed
for a stand-alone enterprise. Managing collaborative networks that span various partners across
the value chain is next to impossible using such
systems. Therefore, we foresee a two-tier system

Pharmas Lagging Supply Chain


Operational metrics suggest huge opportunities.

Inventory

258 days
2-4x

153 days

Obsolescence
(% of sales)

3.1%

Manufacturing
Lead Time

72 days

120-180 days

2.8%
6x
0.5%

120-180 days
25-40x
3-7 days

Pharmaceuticals

Medical Devices

Fast-Moving Consumer Goods

Source: Building New Strength in the Healthcare Supply Chain, McKinsey & Co., January 2013.
Figure 1

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composed of traditional on-premises ERP systems, coupled with cloud-enabled collaboration


platforms. Connected sysConnected systems tems can engender trust,
transparency and
can engender trust, ensure
increase accountability by
ensure transparency providing a single version
and increase of the truth.

accountability by
providing a single
version of the truth.

proliferation and product obsolescence, the


fast-moving consumer goods (FMCG) industry
partnered with the retail industry to successfully implement collaborative forecasting and
reduce inventory. Today, collaborative forecasting enables the FMCG industry to operate with
25% to 50% of the inventory of pharmaceutical
companies (see Figure 1, previous page).

Beyond technology, pharmaceuticals organizations


need to invest in building
trust and ensuring that
vendors and customers also receive benefits from
cooperation. This will ensure both real and virtual
collaboration across the value chain and yield
mutually positive outcomes.

The pharmaceuticals industry can achieve similar results if it similarly leverages distributor and
retailer data for sales and operations planning
(S&OP). However, this ideal state is a far cry from
the current practice, in which pharmaceuticals
companies mostly plan in silos to meet financial
targets. Common complaints across the pharmaceuticals supply chain include:

Collaborative Forecasting

The nagging issue of inordinately high


inventory can be addressed, at least in part, by
collaborative demand forecasting. When faced
with similar, if not greater, challenges of SKU

Distributors and retailers accuse manufacturers of channel-stuffing, wherein


distribution channels are loaded with too
much inventory toward the end of fiscal
periods to meet financial targets. This hurts

Quick Take
Technology Enabler #1: Enveloping Core ERP with Cloud
While most stakeholders appreciate the benefits of demand-driven supply, a key impediment to
implementing this model is the lack of tools that can facilitate collaborative forecasting and planning
based on consensus. Although such tools and systems are common in other industries like FMCG and
retail, the pharmaceuticals industry has been slow to adopt them because of its skepticism of cloud solutions in particular and the security of shared data in general.
However, pioneers of software as a service (SaaS) and cloud infrastructure have
made significant progress in data encryption, and supply chain leaders should re-evaluate the merits of creating a cloud-based planning layer over their core ERP. A cloudbased planning layer can enable the sharing of S&OP data with key stakeholders: contract manufacturers, branded and generic business units, distributors and retailers.
This planning layer would enable collaborative and iterative simulation planning that
takes into consideration pertinent factors such as current demand, projected sales
scenarios and supply constraints like lead time and capacity.
Once a forecast and the corresponding supply planning version have been agreed
to by all concerned stakeholders (for example, the brand owner and its contract
manufacturers), the plan can be adopted by the respective ERP systems to dictate lower-level planning like MPS or MRP. Needless to say, this requires the evolution of new data models that can be easily rolled out to multiple sites within the
enterprise and also adopted by new suppliers and customers.

A cloud-based
planning layer can
enable the sharing
of S&OP data with
key stakeholders:
contract
manufacturers,
branded and
generic business
units, distributors
and retailers.

Leading pharmaceuticals manufacturers are already starting to realize that when they have close to
100 contract manufacturers in different regions, integrating these manufacturers into their core ERP
would take several years. They are looking to cloud offerings to provide almost instant connectivity and
the ability to maintain a complex and scalable network, regardless of the number of interfaces involved.

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logistics providers directly and manufacturers


in the long run because of the costly and
often complicated processing of unsold and
expired inventory returns.
Manufacturers complain that distributor
inventory data is not readily available and
that delays in receiving their demand projections at the SKU level adversely affect their
master production schedule
While vaccine and (MPS) and material requiresterile operations ments planning (MRP).
manufacturers Companies managing
external suppliers or
are adopting a
contract manufacturers
with relatively smaller
collaborative
contracts often find them
S&OP model, most
to be inflexible in switchpharmaceutical
ing the supply of SKUs if
needed.
manufacturers are

still struggling to
instantiate this
model, especially
when it comes to
sharing forecasts
outside their
four walls.

While vaccine and sterile


operations
manufacturers
are adopting a collaborative
S&OP model, most pharmaceutical manufacturers are
still struggling to instantiate
this model, especially when
it comes to sharing forecasts
outside their four walls.

In summary, the pharmaceuticals industry is


not very responsive to changes in demand.
This is due to both structural problems (a long
supply chain network with multiple nodes and
long manufacturing lead times involving multiple
quality checks), the absence of information sharing on inventory disposition and the rate of depletion of inventory at each node of the supply chain
network on a real-time or near real-time basis.

Visibility
The global populations rapidly growing healthcare needs present a mission-critical purpose
for pharmaceutical manufacturers. Pharmaceuticals product manufacturing and replenishment
must be tightly managed to avoid stockouts,
because unlike stockouts in other industries, they
sometimes entail a life-or-death situation.

level, is insufficient for pharmaceutical supply


chains, as they deal with tremendous challenges
in product diversion and product recalls, product
counterfeiting and adulteration, and evolving
global regulatory requirements.
In addition to frequency and speed of replenishment, compliance requirements such as
serialization,
e-pedigree
and
traceability
reporting are emerging in the U.S. (in California
and at the federal level), China, India, Argentina,
Brazil, Turkey, the European Union and elsewhere.
These regulations expected to cover nearly
70% of global drug production and distribution
by 20175 demand that every sellable unit has
the following characteristics:

Trackability in the supply chain. The


organization needs to be certain of the units
location, whether it faces the risk of imminent
expiry or spoilage and if it is still progressing
through legitimate channels.
Traceability to its upstream supply chain
events, such as packaging and the commissioning and decommissioning of pallets.
The vision is to generate an improved level of
transparency for inventory, warehouse and logistics data, which will ultimately enable a more
responsive and secure supply chain. However,
to achieve visibility at this level across distribution networks and up to the patients bedside,
global solutions need to be implemented through
a partnership of key supply chain players. Collaboration is key because the supply chain is only as
strong as its weakest link. Unless all stakeholders
manufacturers, distributors, 3PL providers and
retailers are onboard, end-to-end visibility will
be difficult, if not impossible, to realize.
The previously mentioned regulatory mandates
have already forced industry leaders regardless of the role they play in the pharmaceutical
supply chain to collaborate on developing and
adopting universal technology and infrastructure standards (e.g., 2-D barcode, RFID and GS1
interface standards).

Adaptive Supply Chains


Product visibility is an important component of
agile supply chains. Visibility enables organizations to adapt to demand variability, enhance
supply chain security and meet regulatory compliance needs. Analyzing product data at an
aggregated level, rather than at the sellable unit

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The majority of pharmaceutical products are


managed by a uniform supply chain with little to
no adaptation for the specific product or market
that it serves. This forces high inventory and service levels for all products, regardless of need.
As margins decline and competition increases,

Quick Take
Technology Enabler #2: Cloud-based Master Data for Tracking, Tracing
Managing collaborative networks through existing on-premise ERP systems is difficult. A growing
consensus agrees this is best done through an independent cloud-based supply chain collaboration
platform that allows each player in the supply chain to connect to the central
system regardless of its own IT infrastructure. The network approach followed by This approach is
the cloud platform enables customers to more quickly and cost-effectively build being embraced
scalable master data platforms (GTIN, UPC, e-pedigree, etc.) and transactional data
(commissioning events, repackaging, delivery, etc.). Costs are lower partly because by leading
of the decreased total cost of IT and partly because of the lower cost of integration pharmaceuticals
using standard data models, plug-ins/APIs, etc.
manufacturers
Independent cloud solutions for serialization and track-and-trace will also mitigate
challenges typically faced when implementing serialization initiatives, such as
long equipment lead times, a limited talent pool, uncertainty around how
data will be shared, whether the mandates timeline will change, change
management risks from an operational standpoint, and layering in new systems
and validating them. We see organizations migrating toward cloud-based service
providers to address their track-and-trace needs and build a single source of truth
for all aligned players.

to comply with
mandates around
serialization,
extend compliance
to partners
and leverage
efficiencies across
the extended
supply chain.

Areas where we see progress include hosting and data exchange management to
achieve track-and-trace reporting, event acquisition, storage and reporting, product authentication, and reporting and sharing requisite data with supply chain
partners. Such solutions are provided by mobile and cloud-based serialization products, service providers and systems integrators that are able to host collected data on- or off-premise and then share
required data with partners and regulatory agencies.
Many of these providers are now even offering serialization solutions such as SaaS hosted on the
cloud. This approach is being embraced by leading pharmaceuticals manufacturers to not only comply with mandates around serialization, but to also extend compliance to contract manufacturing
partners and truly leverage efficiencies across the extended supply chain.

the pharmaceuticals industry and its products


particularly generics will begin to resemble the
consumer goods industry.
As this occurs, the most competitive pharmaceuticals companies, like consumer goods companies, will require several supply chains, each
adapted to serve a particular market, product
type or product lifecycle stage.

manufacturers positioned close to suppliers and


customers to provide products tailored for unique
local requirements. The new
The new model
model will more closely
resemble todays consumer will more closely
goods supply chains, which resemble todays
are able to supply low-marconsumer goods
gin products at low prices
almost without interruption. supply chains, which

While the supply chain for a new high-margin drug


under patent protection may resemble the current
one with production located in the innovating
companys facilities and a highly complex supply
chain the supply chain for an older drug or one
competing with generics must look very different
and be focused on cost competition. Such a supply chain will utilize global networks of contract

The traditional pharmalow-margin products


ceutical
supply
chain
requires, on average, 75 at low prices almost
days for pharmaceutical without interruption.
products to reach distribution centers from manufacturing plants. However, several leading companies have reduced
lead times to 30 days by adapting their supply

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are able to supply

chains to align with product characteristics and


customer requirements (see Figure 2). This
segmentation is only possible through collaboration among suppliers, manufacturers and
3PLs because no single party may possess all
necessary data points.
A more adaptable network of manufacturing facilities enables organizations to source drugs from
production facilities appropriate to the manufacturing processs infrastructure and environmental requirements. Highly complex or new drugs
require expensive facilities to produce. However,
low-complexity drugs are often also produced
at these facilities to offset the sites overhead,
requiring the facility to be larger and more costly
than needed.
The average pharmaceutical manufacturing facility operates well below capacity, due to factors
such as over-design, the use of numerous setups
to accommodate a multitude of products and the
difficulties of maintaining up-time in highly complex systems. Efficiency can be improved by segmenting the production of low-complexity drugs
(which often involves little more than formulation) to more cost-efficient, low-sophistication
contract manufacturers, as well as consolidating
the production of complex drugs to fewer sophisticated plants.

Likewise, warehouse and logistics capacities are


also inefficiently utilized. This is particularly the
case for cold chain products, whose distribution is
growing twice as quickly as the biopharmaceuticals industry as a whole.
In the next decade, a pharmaceuticals manufacturing network will become a source of competitive advantage. To enable segmentation, flexible
global networks of manufacturers with different
capabilities are required.
And to improve processes, Both pharmaceutical
manufacturers need to be and contract
offered incentives, such as
manufacturers
a share of the benefits they
generate. For this to occur, will need to
both pharmaceutical and provide levels
contract manufacturers will
of transparency
need to provide levels of
transparency not found in not found in
relationships today. A trust- relationships today.
ing, long-term relationship
based on benefits-sharing will boost confidence in
the contract manufacturers ability to deliver consistent, compliant products and greater flexibility.
When a manufacturer is confident that it will be
treated fairly, changes to production schedules
and volume can be made more rapidly than would
be possible through contract amendment.

Finished Goods Lead


Time (weeks)

Segmented Supply Chains Improve Service Levels,


Reduce Supply Chain Planning Costs
8-26

4-8
3-4

~2

Finished Goods
Manufacturing
Frequency (weeks)

8-52

4-12

Low volume,
high volatility

4-8

Low volume,
low volatility

High volume,
high volatility

2-4

High volume,
low volatility

Source: Building New Strength in the Healthcare Supply Chain, McKinsey & Co., January 2013.
Figure 2

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Quick Take
Technology Enabler #3: ERP, Advanced Network Planning System
Integration
Best-in-class pharmaceutical companies are instituting a new supply chain operating model that enables
segmentation across the network. As a result, these companies now have a synchronized regional, site
and network supply chain. This gives them a shared view of the plan across the network and a way
to enable waste reduction, risk mitigation, effective lifecycle management, jurisdictional control and
scalability as business complexity continues to grow.
To be effective, these networks will require an exchange of data that goes far beyond the traditional
sharing of tactical data. Further, data will need to be available on-demand, in near real-time. The
comparative ease with which cloud-based collaboration systems are implemented means that data held
in systems outside of ERP (CAPA, MES or LIMS, for example) can be shared on the same cloud platform.
Such data sharing enables effective monitoring of manufacturing processes and can provide early
warnings of problems in internal and external operations.

Looking Ahead
The pharmaceuticals supply chain has been
challenged to reduce costs to counter dramatic
changes in the business environment. To
succeed, pharmaceuticals companies that have
traditionally focused inwardly must re-define
the boundaries of their enterprise. Suppliers
typically regarded as outside the four walls,
including CMOs, 3PLs and retailers, will become
partners in a virtual supply chain and function
more as captive suppliers. In some cases, they will
function as an extension of the company itself and
not be viewed as mere transactional partners.
We recommend three short- to medium-term
initiatives to improve supply chain performance
through enhanced collaboration:

Reduce inventory levels and product


obsolescence costs by implementing cloudbased ERP interfaces, collaborative forecasting and production planning.

Leverage track-and-trace requirements to


build systems that not only meet compliance
requirements but also provide SKU-level
inventory, replenishment and demand data
directly from downstream partners to get
ahead of demand shifts and facilitate an agile
supply chain.
Reduce manufacturing and logistics costs
by adapting supply chains to serve specific
products and markets.
The success of these initiatives depends on a
supply chain organization that is both supported
and driven by executive leadership who embrace
the concept of true collaboration enabled by
cloud-based and other pertinent technologies.
Pharmaceuticals firms will need partners who
can share and apply best practices from industries that have undergone similar changes to
help with their organizational and technology
transformations.

Footnotes
1

S&P CapitalIQ

Optimism Tempered by Reality in a New Normal, Deloitte, 2013, http://www.deloitte.com/assets/


Dcom-Ireland/Local%20Assets/Documents/Life%20sciences/2013%20Global%20Life%20
Sciences%20Sector%20Report.pdf.

Phil Berk, Marc Gilbert, Marc Herlant and Gideon Walter, Rethinking the Pharma Supply Chain,
BCG Perspectives, The Boston Consulting Group, May 13, 2013, https://www.bcgperspectives.com/
content/articles/biopharma_supply_chain_management_rethinking_pharma_supply_chain_new_
models_new_era/.

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Thomas Ebel, Erik Larsen and Ketan Shah, Building New Strengths in the Healthcare Supply Chain,
McKinsey & Co., January 2013, http://www.mckinsey.com/insights/health_systems_and_services/
strengthening_health_cares_supply_chain_a_five_step_plan.

Global Track and Trace, Tracelink Web site, http://tracelink.com/safe-secure-global-distributionserialization-pedigree-solutions?gclid=CMj_rMCy5rkCFVNo7Aod6yEA2w.

Acknowledgments
The authors would like to acknowledge the contributions of Eric Laager, Senior Consultant in
Cognizant Business Consultings Life Sciences Practice, and Anirban Ghosh, Senior Consultant in
Cognizant Business Consultings Life Sciences, to this white paper.

Credits
Authors
Ramana Reddy, AVP, Cognizant Business Consulting, Life Sciences Practice
Sandeep Gidwani, Director, Cognizant Business Consulting, Life Sciences Practice
Sanjay Fuloria, PhD, Senior Researcher, Cognizant Research Center

Analyst
Yuvaraj Velusamy, Researcher, Cognizant Research Center

Design
Harleen Bhatia, Design Team Lead
Meenakshisundaram Thambusamy, Designer

About Cognizant
Cognizant (NASDAQ: CTSH) is a leading provider of information technology, consulting, and business process
outsourcing services, dedicated to helping the worlds leading companies build stronger businesses. Headquartered
in Teaneck, New Jersey (U.S.), Cognizant combines a passion for client satisfaction, technology innovation, deep
industry and business process expertise, and a global, collaborative workforce that embodies the future of work.
With over 50 delivery centers worldwide and approximately 164,300 employees as of June 30, 2013, Cognizant is a
member of the NASDAQ-100, the S&P 500, the Forbes Global 2000, and the Fortune 500, and is ranked among the
top performing and fastest growing companies in the world.
Visit us online at www.cognizant.com for more information.

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